MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. AVANTA FLUID MANAGEMENT SYSTEM; ANGIOGRAPHIC INJECTOR

Model Number	60726742
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the avanta fluid management system, serial number (b)(4), was performed on (b)(6) 2019 at which time the equipment was confirmed to be operating to specification.This investigation remains in progress.Once the investigation is completed, a follow-up report will be submitted.This information does not constitute an admission that the device, the company or its employees caused or contributed to a reportable event.
Event or Problem Description
On (b)(6) 2019, the customer reported that a patient suffered a cardiac arrest after an undisclosed amount of air was allegedly injected while connected to an avanta fluid management system.Post resuscitation, a balloon pump was inserted and the patient was transferred to the intensive care unit (icu) in stable condition for further evaluation and care.
Additional Manufacturer Narrative
A system service check of the avanta fluid management system, serial number (b)(6), was completed on (b)(6) 2019 which confirmed that the injector was operating within bayer specifications.Product analysis received and examined the returned multi-patient sterile disposable set (mpat, lot number unknown) and single-patient sterile disposable set (spat, lot number unknown) that were used during the procedure.Visual examination determined that the disposables were in good overall condition with no observable defects or damage noted.Functional testing concluded that the disposables performed to specification with no problems observed.The avanta fluid management system operation manual cautions the user as follows: "warning: expel all air from the syringe, drip chambers, connectors, tubings, transducer, and catheter before connecting the system to the patient." the offer of additional clinical applications training was declined by the customer.The site continues to use the avanta fluid management system after the reported event.No further issues were reported.This information does not constitute an admission that the device, the company or its employees caused or contributed to a reportable event.

• Brand Name: AVANTA FLUID MANAGEMENT SYSTEM
• Common Device Name: ANGIOGRAPHIC INJECTOR
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 8989333
• Report Number: 2520313-2019-00039
• Device Sequence Number: 19549956
• Product Code: DXT
• UDI-Device Identifier: 00616258008578
• UDI-Public: (01)00616258008578
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60726742
• Device Catalogue Number: AVA 500 PEDL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 62